WARNING
RETROVIR (ZIDOVUDINE) HAS BEEN ASSOCIATED WITH HEMATOLOGIC TOXICITY INCLUDING NEUTROPENIA AND SEVERE ANEMIA PARTICULARLY IN PATIENTS WITH ADVANCED HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE (SEE WARNINGS). PROLONGED USE OF RETROVIR HAS BEEN ASSOCIATED WITH SYMPTOMATIC MYOPATHY.
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION, INCLUDING RETROVIR AND OTHER ANTIRETROVIRALS (SEE WARNINGS).
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RETROVIR SUMMARY
RETROVIR®
(zidovudine)
Tablets
RETROVIR®
(zidovudine)
Capsules
RETROVIR®
(zidovudine)
Syrup
RETROVIR is the brand name for zidovudine (formerly called azidothymidine [AZT]), a pyrimidine nucleoside analogue active against human immunodeficiency virus (HIV).
RETROVIR in combination with other antiretroviral agents is indicated for the treatment of HIV infection.
Maternal-Fetal HIV Transmission: RETROVIR is also indicated for the prevention of maternal-fetal HIV transmission as part of a regimen that includes oral RETROVIR beginning between 14 and 34 weeks of gestation, intravenous RETROVIR during labor, and administration of RETROVIR Syrup to the neonate after birth. The efficacy of this regimen for preventing HIV transmission in women who have received RETROVIR for a prolonged period before pregnancy has not been evaluated. The safety of RETROVIR for the mother or fetus during the first trimester of pregnancy has not been assessed (see Description of Clinical Studies).
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NEWS HIGHLIGHTSMedia Articles Related to Retrovir (Zidovudine)
Retrovirus Linked to Chronic Fatigue Syndrome
Source: MedicineNet Chronic Fatigue Syndrome Specialty [2009.10.09]
Title: Retrovirus Linked to Chronic Fatigue Syndrome
Category: Health News
Created: 10/9/2009 10:24:00 AM
Last Editorial Review: 10/9/2009 10:24:19 AM
Lagging Funding From U.S., Other Countries Threatens HIV/AIDS Progress, Doctors Without Borders Says
Source: Tropical Diseases News From Medical News Today [2009.11.10]
Global economic problems and other factors have slowed public health funding from the U.S. and other international donors, threatening recent gains in providing antiretroviral drugs to people with HIV/AIDS in developing countries, according to a new report by Doctors Without Borders, the
Taking Medicine For HIV Proves Hard To Swallow For Many People
Source: Compliance News From Medical News Today [2009.10.23]
Highly active antiretroviral therapy has increased the longevity and quality of life for people living with human immunodeficiency virus. But it requires strict adherence in taking the medicine, something that is extremely difficult for many individuals to do. Two new University of Washington studies illustrate just how hard it is to make sure people take their HIV medication.
Published Studies Related to Retrovir (Zidovudine)
A randomized comparative trial of continued zidovudine/lamivudine or replacement with tenofovir disoproxil fumarate/emtricitabine in efavirenz-treated HIV-1-infected individuals. [2009.08.15]
BACKGROUND: Long-term antiretroviral therapy dramatically reduces HIV-related morbidity and mortality but is also associated with metabolic and morphological changes and requires high levels of adherence... CONCLUSIONS: Switching from zidovudine/lamivudine to tenofovir disoproxil fumarate/emtricitabine in persons on efavirenz therapy maintains virological control, establishes a once-daily regimen, results in improvements in hemoglobin and key lipid parameters, and preserves and restores limb fat relative to continuation of zidovudine/lamivudine.
Loss of bone mineral density after antiretroviral therapy initiation, independent of antiretroviral regimen. [2009.08.15]
BACKGROUND: Decreased bone mineral density (BMD) has been described in HIV-infected patients initiating antiretroviral therapy (ART), but the contributions of ART and immunologic and/or virologic factors remain unclear... CONCLUSIONS: Similar decreases in BMD over 96 weeks occurred in ART-naive subjects receiving either EFV-based regimen or LPV/r-based regimen, which was not altered by simplification to LPV/r monotherapy and was unrelated to markers of tumor necrosis factor-alpha activity.
Lower risk of resistance after short-course HAART compared with zidovudine/single-dose nevirapine used for prevention of HIV-1 mother-to-child transmission. [2009.08.15]
BACKGROUND: Antiretroviral resistance after short-course regimens used to prevent mother-to-child transmission has consequences for later treatment. Directly comparing the prevalence of resistance after short-course regimens of highly active antiretroviral therapy (HAART) and zidovudine plus single-dose nevirapine (ZDV/sdNVP) will provide critical information when assessing the relative merits of these antiretroviral interventions... CONCLUSIONS: Our finding provides evidence that compared with ZDV/sdNVP, HAART reduces but does not eliminate nevirapine resistance.
A combination drug of abacavir-lamivudine-zidovudine (Trizivir) for treating HIV infection and AIDS. [2009.07.08]
CONCLUSIONS: Our findings indicate that Trizivir remains a viable option for initiating antiretroviral therapy, especially in HIV-infected patients with pre-existing hyperlipidaemia and those who do not tolerate ritonavir.
The effect of individual antiretroviral drugs on body composition in HIV-infected persons initiating highly active antiretroviral therapy. [2009.07.01]
OBJECTIVE: To examine the long-term effects of individual antiretroviral drugs on body composition among 416 persons initiating antiretroviral therapy (ART)... CONCLUSION: In this prospective nonrandomized evaluation, the nucleoside reverse transcriptase inhibitors d4T and ZDV were associated with decreases in subcutaneous tissue areas, whereas 3TC use was associated with increased subcutaneous tissue areas and waist nonsubcutaneous tissue area.
Clinical Trials Related to Retrovir (Zidovudine)
Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine [Active, not recruiting]
Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown
to be active in vitro against a wide range of clinical isolates (including those resistant to
existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy
for 10 days reduced HIV-1 viral load by up to 1. 6 log, consistent with currently available
agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at
300 mg twice daily. No significant effects were seen on the QTc interval. The goal of this
study is to compare the safety and efficacy of maraviroc (UK-427,857) versus efavirenz, when
each are combined with two other antiretroviral agents, in patients who are previously naive
to antiretroviral therapy. This study will involve approximately 200 centers from around the
world to achieve a total randomized subject population of 1071 subjects. Patients will be
randomly assigned to one of three groups: maraviroc (UK-427,857) 300 mg once daily added to
zidovudine/lamivudine (300 mg/150 mg twice daily), Maraviroc (UK-427,857) 300 mg twice daily
added to zidovudine/lamivudine (300 mg/150 mg twice daily) or efavirenz (600 mg once daily)
added to zidovudine/lamivudine (300 mg/150 mg twice daily). The study will enroll over
approximately an 18 month period (5 months Phase 2b run-in, 13 months Phase 3) with 96 weeks
of treatment. This may be extended for an additional 3 years depending on the results at 96
weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24,
32, 40, 48, 60, 72, 84 and 96. Blood samples will also be taken at study entry, weeks 2, 4,
8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Additionally, blood samples will be drawn
twice, at least 30 minutes apart, at weeks 2 and 48 for maraviroc (UK-427,857)
pharmacokinetic analysis. As part of this clinical study a blood sample will be taken for
non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram
at study entry, weeks 24, 48 and 96. A computerized tomography (CT) scan will also be
performed, at selected centers, at study entry and week 96. Patients will be asked to
complete a symptom distress questionnaire at study entry, weeks 12, 24, 48 and 96.
A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir ( AZT ) and HIVID ( ddC ) Versus Retrovir, HIVID, and Wellferon ( Interferon Alfa-n1 ) for the Treatment of HIV Infection [Completed]
Primary: To determine whether the combination of zidovudine/zalcitabine/interferon alfa-n1
(Retrovir/HIVID/Wellferon) can produce complete responses (i. e., CD4 counts return to >= 800
cells/mm3 for more than 24 weeks) in patients with virus sensitive to all three agents. To
determine the antiviral effect of the combination therapies as evidenced by measures of
quantitative viral load performed at select study centers only.
Secondary: To determine the effectiveness of Retrovir/HIVID and Retrovir/HIVID/Wellferon in
maintaining or increasing CD4 counts and preventing disease progression as evidenced by the
development of an AIDS-defining indicator disease. To determine the effect of these regimens
on secondary measures of clinical status (e. g., performance score, weight change, and
secondary infections) and on measures of virologic activity such as serum p24 antigen. To
assess the safety and tolerance of these regimens.
A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cell [Completed]
PRIMARY: To compare the virologic activity (quantitative RNA PCR, quantitative PBMC) of the
combination of nevirapine and zidovudine (AZT) versus AZT alone after 3 and 6 months of
treatment. To compare the effects of these two regimens on CD4 T-cell count and percentage.
SECONDARY: To compare and evaluate other markers of immunologic and virologic activity in
patients receiving nevirapine/AZT versus AZT alone. To compare the effects of the two
regimens on clinical signs and symptoms. To evaluate the safety and tolerance of the two
regimens.
A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases [Completed]
The purpose of this pilot study is to evaluate the efficacy of Retrovir (AZT) in the
treatment of AIDS-related dementia and various neuromuscular complications. HIV is both a
lymphotropic and neurotropic virus which can affect both the central and peripheral nervous
systems (CNS, PNS). There is evidence that the CNS and PNS may harbor the virus in a latent
state, with the potential for continuous reinfection of other body systems. Therefore,
effective therapeutic efforts against HIV infection should provide effective antiviral
activity within the nervous system.
A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease [Active, not recruiting]
To facilitate the use of zidovudine (AZT) in children who are 3 months to 12 years of age who
are HIV-infected and either symptomatic or have a CD4 cell count < 400 cells/mm3 and to
monitor adverse effects of AZT.
Previous studies with pediatric patients have shown improvements in clinical, immunologic,
and virologic parameters with administration of AZT.
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Page last updated: 2009-11-10
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